Citalopram for Reflux Hypersensitivity and Functional Heartburn
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03499171|
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : December 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|GERD||Drug: Citalopram 20mg Drug: Placebo Oral Tablet||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Placebo-controlled Trial With Citalopram for the Treatment of Typical Reflux Symptoms in Patients With Reflux Hypersensitivity or Functional Heartburn With Incomplete Proton Pump Inhibitor Response|
|Estimated Study Start Date :||December 2018|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
20mg, once a day
Drug: Citalopram 20mg
Citalopram is taken once a day as an add-on to PPI treatment (2x/d).
Placebo Comparator: Placebo
Once a day
Drug: Placebo Oral Tablet
Placebo is taken once a day as an add-on to PPI treatment (2x/d)
- change in number of reflux episodes [ Time Frame: 8 weeks ]The primary efficacy endpoint will be the change in number of reflux episodes assessed by 24 hour impedance-pH monitoring.
- change in reflux parameters [ Time Frame: 8 weeks ]change in reflux parameters (number of reflux episodes with a high proximal extent, volume exposure) assessed by 24 hour impedance-pH monitoring,
- change in esophageal sensitivity [ Time Frame: 8 weeks ]change in esophageal sensitivity assessed by multimodal esophageal stimulation procedure
- change in symptom severity [ Time Frame: 8 weeks ]change in symptom severity assessed by validated reflux questionnaires (ReQuest questionnaire and diaries). Patients will have to indicate the symptom occurence and symptom severity on a scale. Two words, on each site of the scale indicate their symptom severity (on the left "totally not present" on the right "very strong present"). A higher score represents a worse outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499171
|Contact: Hannelore Geysen||+32 (0)16 email@example.com|
|Leuven, Belgium, 3000|
|Contact: Hannelore Geysen +32 (0)16 324921 firstname.lastname@example.org|